MHRA Final Rules for Post-Market Surveillance
Medicines and Healthcare Products Regulatory Agency (MHRA) finaliz...
The Role of Clinical Monitoring in the Success of Medical Device Trials in the USA
Clinical monitoring is an indispensable component of the medical d...
US FDA Traditional 510(K) Submission – A Step by Step Process
In the United States, medical devices are regulated under the Fede...
US FDA Medical Device Labeling Requirements
What Is Medical Device Labeling?
According to the FDA, medical dev...
In Vitro Diagnostic Regulation (IVDR) – General Aspects, Key features and Limitations
Introduction to IVDR:
The In Vitro Diagnostic Regulation (IVDR) re...
Technical Documentation Best Practices for EU MDR
Manufacturers shall ensure the conformity of medical devices being...
